The present invention relates to the field of minimally-invasive internal surgery, and more particularly, to methods and apparatus for suturing within a patient body via the manipulation of devices external to a patient body.
Minimally invasive internal surgery procedures are ever-increasing. Such procedures typically entail the insertion of a tubular member into a patient body and the passage of various devices through the tubular member to access a tissue site of interest. In laparoscopic procedures, a plurality of tubular members, e.g., trocars, may be inserted through offset incisions and advanced proximal to the tissue site of interest. The tubular members utilized are relatively rigid and of a diameter sufficient to facilitate the passage of a wide variety of devices therethrough, including for example the passage of gas inflation conduits, electrosurgical devices, imaging apparatus and suturing devices. As may be appreciated, laparoscopic surgical procedures include those directed to fundoplications, myomectomies, splenectomies, herniorrhaphies and cholecystectomies.
In endoscopic procedures, a single tubular member is typically inserted through a bodily orifice to provide instrumentation access therethrough to an internal tissue site, e.g., through the mouth or anus to access a hollow organ. Given such access points and associated bodily canals, the tubular members utilized in endoscopic applications are necessarily of flexible construction and may be of significant length. Such considerations present particular challenges in the design and development of endoscopic surgical apparatus and techniques. To date, endoscopic procedures have been largely limited to gasdroesophergeal (GERD) and biopsy applications. However, it is believed that new surgical devices and procedures may be developed that facilitate increased endoscopic applications involving the ligating, proximating and suturing of tissue in the stomach and colon.
Common to both laparoscopic and endoscopic surgical procedures is the need to effectively suture an internal tissue site of interest. Such suturing entails the passage of a suture material into and back out of the tissue at least once, and most typically a plurality of times, followed by the provision and tightening of a knot adjacent to the sutured tissue. As may be appreciated, the completion of suturing procedures in laparoscopic and endoscopic applications can present a challenging and sometimes tedious task for surgical personnel. For example, such suturing procedures may involve difficult manipulation of an external device to cause an internally located needle to pass entirely through tissue at a surgical site to effect suture stitching. Further, in some approaches, the provision of a suture knot at a sutured site may require the time-consuming removal and reinsertion of the entire suturing apparatus and access tubing therefor.
In view of the foregoing, a broad objective of the present invention is to provide methods and apparatus for internal suturing that are relatively simple to employ yet highly effective.
An additional objective of the present invention is to provide for internal suturing in a manner that reduces componentry cost and complexity.
Another objective of the present invention is to provide for internal suturing in a manner that reduces the overall time required for suturing in a given procedure.
Yet a further objective of the present invention is to provide for internal suturing in a manner that accommodates a wide variety of applications.
An additional objective of the present invention is to provide for internal suturing in a manner that allows for substantially continuous imaging of the entire suturing process.
One or more of the above-noted objectives and additional advantages are realized in a suturing apparatus that comprises a needle member having a distal end portion and a suture material having a pre-tied knot (e.g., a Roeder knot) initially disposed about the distal end of the needle member. As will be appreciated, the needle member may be of a length sufficient to permit external manipulation of a proximal end so as to xe2x80x9cthreadxe2x80x9d the suture material through tissue at a surgical site.
In one aspect of the invention, the apparatus further includes a first member disposed for selective relative movement between the first member and the needle member. Upon such relative movement, the first member is positionable to engage the suture material and thereby position the pre-tied knot beyond the distal end of the needle member, e.g., for subsequent tightening at a surgical site. By virtue of this arrangement, the provision of a suture knot at a sutured site may be accurately and readily accomplished.
The distal end of the needle member may comprise piercing tip. By way of example, such piercing tip may be of a straight or arcuate configuration. Correspondingly, the needle member may be provided so that rotation of a proximal end portion thereof effects substantially co-rotational movement of the piercing tip through a corresponding arc. As will be appreciated, such co-rotational movement facilitates the desired passage, or stitching, of the piercing tip of the member needle into and back out of tissue at a surgical site during suturing procedures. In this regard, it may be preferable to provide a needle member having a torsional strength of at least about 0.02 in. lb. and having buckle strength of at least about 0.2 psi from the distal end to a proximal end thereof.
To facilitate use in endoscopic applications, the needle member may be elongated, with a maximum cross-sectional width, or diameter, of about 0.10 inches. Additionally, for such applications the elongated needle member may preferably comprise a resilient material that permits a degree of flexural curvature along the length thereof. By way of example, the elongated needle member may comprise a material selected from a group consisting of nickel, titanium or nickel titanium alloys, stainless, spring or surgical steel, or flexible plastic.
The inventive apparatus may further comprise a second member having a distal end adapted for cutting the suture material, wherein the second member and at least one of the first member and the needle member are disposed to permit selective relative movement therebetween. More particularly, the second member may be disposed for selective advancement/retraction relative to each of the first member and the needle member. Such an arrangement facilities selective positioning of the second member in a forward position for cutting the suture material, e.g., after tissue has been stitched and a pre-tied knot has been placed/tightened at a given surgical site.
In another aspect of the present invention, a suturing apparatus is provided comprising a needle and suture material having one end anchored near a distal end of the suture needle. Again, the apparatus may be designed so that the needle may be externally manipulated to thread the suture material through tissue at an internal surgical site. The suturing apparatus also includes a grasping member, wherein the needle and grasping member are disposed to permit selective relative movement therebetween. Upon such selective relative movement the grasping member is positionable beyond a distal end of the needle for selectively grasping and/or releasing the suture material, e.g., after threading of the suture material through tissue at a surgical site.
In conjunction with this aspect of the invention, the grasping member may be positioned through at least a portion of the needle, e.g. a hollow piercing tip at the distal end of the needle, and adapted to telescope therebeyond upon selective relative movement therebetween. Further, the grasping member may comprise a spring-loaded portion, (e.g., the grasping member may be shaped to exhibit a spring-loaded behavior), wherein the spring-loaded portion collapses to a non-deployed state upon positioning within a hollow piercing tip of the needle and automatically springs open to a deployed state upon positioning beyond the distal end of the needle. In one embodiment, the spring-loaded portion of the grasping member may be of a hoop-like configuration for selective positioning about an end portion of suture material in a deployed state and for capturing the end portion therethrough in a non-deployed state (e.g., when retracted within the hollow piercing tip of the needle).
In one arrangement implementing various inventive aspects, a suturing apparatus is provided which includes a grasping member, a needle member, a knot positioning member and a suture cutting member, each of which extend in a parallel fashion from a distal end to a proximal end of the suturing apparatus. For example, such members may be disposed in a concentric manner, e.g., wherein the grasping member is located through the needle member, the needle member is positioned through the knot positioning member and the knot positioning member extends through the suture cutting member. In turn, adjacent ones of said members may be disposed to allow for selective advancement/retraction and/or rotation relative to one another via the manipulation of corresponding handles provided at their respective proximal ends. As will be appreciated, in use of the suturing apparatus, the proximal handles may be interconnected for separate manipulation outside a patient body to effect a desired suturing procedure at an internal tissue site adjacent to distal ends of the corresponding grasping, needle, knot positioning, and suture cutting members.
A suturing apparatus having one or more features as described above is particularly well-suited for system applications. In this regard, and in yet another aspect of the present invention, an inventive suturing system is provided that includes a tubular member adapted for insertion into a patient body, an imaging device positioned through the tubular member for acquiring images within an image view range at the distal end of the tubular member, and a suturing apparatus positioned through an accessory part of the tube member for suturing adjacent to the distal end of the tubular member. The suturing apparatus includes a suture needle that is selectively advanceable/retractable within the image view range of the imaging device.
In conjunction with this aspect of the invention, the suturing apparatus may include a suture material having a pre-tied knot disposed about the suture needle. The suturing apparatus may further comprise a first member. The suture needle and first outer member may be disposed to permit selective relative movement therebetween, wherein upon such selective relative movement the first member is positionable to dispose the pre-tied knot beyond a distal end of the suture needle for selective advancement and tightening at a surgical site within the image view range of the imaging device.
To facilitate real-time viewing of the suturing process, a display device may be included within the system to display the acquired images. As will be appreciated, such display device may be advantageously positioned for observation by a user contemporaneous with the user""s manipulation of the suturing apparatus. In the latter regard, the suturing apparatus may further include additional features as noted hereinabove.
In yet a further aspect of the present invention, one or more inventive methods for internal suturing are provided. In one aspect, an inventive suturing method provides for the retention of an end portion of a suture material at a distal end of a suture needle and the advancement of a limited portion of the suture needle through a patient tissue site, wherein the end portion of suture material is pulled through the patient tissue site by the suture needle. Thereafter, the end portion of the suture material may be selectively released by the distal end of the suture needle and the limited portion of the suture needle may be withdrawn from the patient tissue site, thereby leaving the end portion of the suture material protruding from the tissue site. In turn, the protruding end portion may then be grasped and a pre-tied knot portion of the suture material may be positioned about the grasped end portion. As may be appreciated, such methodology avoids the need to pass a needle completely through a tissue site in order to complete a stitching process. Rather, in the described method, a suture needle may be utilized one or more times to pull the end of a suture material through a tissue site, with the needle being withdrawn back through the tissue site after each occurrence.
In conjunction with the inventive method, the retention of suture material at a distal end of a suture needle may be accomplished by grasping the end portion of the suture material and pulling the grasped end portion into a hollow portion (e.g., a hollow piercing tip) comprising the distal end of the suture needle. Subsequently, the grasped end portion may be released by advancing the grasped end portion back out of the hollow portion of the needle.
In further relation to the inventive method, positioning of the pre-tied knot portion may be achieved by advancing the pre-tied knot relative to the grasped end portion of the suture material so as to tighten the pre-tied knot portion adjacent to the tissue site. In conjunction with such positioning, the grasped end portion of the suture material may be pulled into a hollow portion at the distal end of the suture needle. After knot tightening, the suture material may be selectively cut, e.g., via selective contact with a cutting surface.
Additional aspects and advantages of the present invention will become apparent upon further consideration of the description that follows.